Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01848158
Eligibility Criteria:
Inclusion Criteria:
* age ≥6 months to \<18 years
* intubated and mechanically ventilated
* patient requires pharmacologic sedation/analgesia to tolerate mechanical ventilation
* ≤72 hours of mechanical ventilation at time of enrollment with anticipated need of mechanical ventilation for at least ≥48 hours more (in order to be able to receive at least one acupuncture session)
* approval of treating physician
Exclusion Criteria:
* underlying neurologic condition that could impact sedation/analgesia needs
* coagulopathy (inr ≥ 1.8) or history of spontaneous bruising
* thrombocytopenia (platelets \<20,000 that has not been treated with a platelet transfusion)
* hemodynamic instability (on continuous infusion of vasopressor or inotrope)
* sepsis or bacteremia on antibiotic therapy \<24 hours
* severe generalized skin disorder (e.g., epidermolysis bullosa, Stevens-Johnson)
* ward of state
* being treated with therapeutic level of systemic anticoagulation (e.g., heparin with unfractionated heparin activity level ≥0.3, enoxaparin with low molecular weight heparin activity level ≥0.5, warfarin with inr ≥1.8)
* immunosuppressed (on chemotherapy {e.g., daunorubicin, vincristine}, immunosuppressive medications {e.g., sirolimus, tacrolimus, cyclosporine, mycophenolate mofetil, high dose steroids \>4mg/kg/day}, or immunosuppressive biologics {e.g., thymoglobulin, etanercept, infliximab, adalimumab, rituximab})
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT01848158
Study Brief:
Protocol Section:
NCT01848158